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Sr. Specialist, Systems Engineer
13 hours ago
L3Harris Carlsbad, United StatesJob Title: Sr. Specialist, Systems EngineerJob Code: 11020 · Job Location: Carlsbad, CA · Work Schedule: 9x80 · L3Harris' Communication Systems segment is currently seeking a Sr. Specialist, Systems Engineer to join our team. This position will be based at our Carlsbad, CA facili ...
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Sr. Specialist, Systems Engineer
3 days ago
L3Harris Technologies Carlsbad, United StatesL3 Harris is dedicated to recruiting and developing diverse, high-performing talent who are passionate about what they do. Our employees are unified in a shared dedication to our customers mission and quest for professional growth. L3 Harris provide Systems Engineer, Specialist, ...
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Sr. Specialist, Systems Engineer
1 week ago
Harris Geospatial Solutions Carlsbad, United StatesJob Title: · Sr Specialist, Systems Engineering · Job Location : Carlsbad, CA · Requisition ID : 8880 · JOB RESPONSIBILITIES: · Closely partners with Product Manager and Program Manager assigned to the project throughout all stages of product development and release to productio ...
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Contracts Specialist
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Acadia Healthcare - CTC Group Carlsbad Carlsbad, United StatesOverview: · **FULLY REMOTE - Contracts Specialist** · **Our Team**: · The Comprehensive Treatment Center Division is part of Acadia Healthcare, the nation's leading provider of treatment and educational programs for individuals who are struggling with behavioral health and chemic ...
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Shipping and Receiving Clerk
1 week ago
Advance Services, Inc. Carlsbad, United StatesCarlsbad, CA · $ $24.00 an hour depending on experience · Monday - Friday day shift · Drug screen and background check Required · **ESSENTAIL DUTIES AND RESPONSIBILITES**: · - Receive and verify daily shipments from small package services and various truck deliveries: match purch ...
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Manufacturing Operations Support Specialist
1 week ago
Dupont Carlsbad, United StatesDuPont Laird RandF Performance Materials, Interconnect Solutions, DuPont Electronics & Industrial · Carlsbad designs and manufactures RF Absorbing Materials, Electrically Conductive Elastomers and Maxair vent panels for use in Commercial Electronics The primary markets served are ...
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Specialist, Cyber Intelligence
5 days ago
L3Harris Technologies Carlsbad, United States**Job Title: Specialist, Cyber Intelligence** · **Job Code: 10675** · **Job Location: Carlsbad, CA** · **Work Schedule: 9x80** · This position is full time, on-site, and in plant at our Carlsbald, CA facility. **Must have a current and active Secret security clearance, and must h ...
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Maintenance Specialist I
6 days ago
Glanbia Nutritionals Carlsbad, United StatesBuilding Maintenance Specialist · At Glanbia Nutritionals Inc., our portfolio centers on dairy and non-dairy nutritional ingredients. We co-innovate and deliver ingredient solutions and precision premixes for use in the mainstream food and beverage, infant and clinical, and funct ...
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EHS Specialist Iii
5 hours ago
Thermo Fisher Scientific Carlsbad, United StatesOur Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working ...
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Facilities Specialist
1 week ago
Upper Deck Carlsbad, United StatesSUMMARYOverviewof the position. · Perform general janitorial and/or custodian duties. Responsible for the overall care of building, carry out cleaning, maintenance, and shipping duties. Works with Safety and Security Specialist to ensure all safety regulations are being followed. ...
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Sr Regulatory Affairs Specialist
4 days ago
Actalent Carlsbad, United States Full timeDescription: · The Sr. Regulatory Affairs Specialist - Europe participates and manages necessary regulatory and project · management activities required for medical device registration and compliance, with a focus on · European Medical Device registration. The candidate must have ...
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Sr Regulatory Affairs Specialist
2 days ago
Actalent Carlsbad, United States Full time*Must have EU regulatory experience with MDD and MDR. · Description: · The Sr. Regulatory Affairs Specialist - Europe participates and manages necessary regulatory and project · management activities required for medical device registration and compliance, with a focus on · Euro ...
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Caseworker Coach I
1 week ago
Catholic Charities Diocese Carlsbad, United States**POSITION TITLE**: Caseworker Coach I, (Residential Support Specialist) La Posada · **REPORTS TO**: Program Manager, Homeless Services, San Diego · **FLSA STATUS**: Non-Exempt · **TIME COMMITMENT**: Full-or Part time (40 hours/ week) 2:30 PM- 11:15 PM · **SALARY**: $ per hour DO ...
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Caseworker Coach I
1 week ago
Catholic Charities Diocese Carlsbad, United States**POSITION TITLE**: Caseworker Coach I, (Residential Support Specialist) La Posada · **REPORTS TO**: Program Manager, Homeless Services, San Diego · **FLSA STATUS**: Non-Exempt · **TIME COMMITMENT**: Full-or Part time (40 hours/ week) Overnight availability required · **SALARY**: ...
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Level Designer
1 week ago
Activision Carlsbad, United States**Requisition ID**: R023238 · **Great Games Start with Great People This is a significant time in our company's history - and one of the most exciting times to join us We are building a culture of collaboration and seeking an imaginative, skillful, and versatile** Level Designer* ...
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Associate Vfx Artist
1 week ago
Activision Carlsbad, United States**Requisition ID**: R023237 · **Great Games Start with Great People This is a significant time in our company's history - and one of the most exciting times to join us. We are building a culture of collaboration and seeking an imaginative, resourceful, and versatile **Associate V ...
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Technical Claims Management Support Employee
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Titan Innovations Carlsbad, United StatesWelcome to WISAG Carlsbad · ... one of the leading service companies in Germany for the areas of Aviation, Facility, and Industry. With more than employees, we are dedicated to providing top-quality services every day. · At WISAG Building Technology, we specialize in technical s ...
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Training as an industrial clerk
1 week ago
Velocity Enterprises Carlsbad, United StatesISS is one of the largest private employers in the world with around employees and is shaping the digital future of buildings through sensor technology and IoT solutions. Our goal is to become the best service organization in the world. Are you ready to take the next step with us ...
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IT Service Desk Support Specialist
3 days ago
Talentry Carlsbad, United StatesIT Service Desk Support Specialist · Carlsbad, CA (Onsite, eventual hybrid) · Direct Hire. 26-30//hr. · Talentry is looking for a Service Desk Specialist to help users resolve computer issues, as well as to perform company projects relating to IT. The right person for this role w ...
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Benefits and Compliance Specialist
1 week ago
Natural Alternatives International, Inc. Carlsbad, United StatesSummary The Benefits and Compliance Specialist is responsible for performing HR-related duties on a professional level and works closely with senior management. This position carries out responsibilities in the following functional areas: benefits administration, policy implement ...
Sr. Quality Systems Specialist - Carlsbad, United States - Katalyst HealthCares & Life Sciences
Description
Responsibilities:
Provides oversight for the maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups through all stages of the audits.
Coordinates legal requests in support of government investigations or litigations.
Ensures the quality assurance programs and policies are maintained and modified regularly.
Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
Responsible for planning, organizing, and editing a variety of RFAIs associated with software, hardware, labeling, post-market vigilance and technical documentation.
Drive Quality Management System (QMS) & product continuous improvement through CAPA management. Elevate issues to management as appropriate.
Coach new CAPA owners through processes and best practice.
Develop and maintain Compliance policies supporting the Risk Management program.
Provide expertise and guidance in interpreting governmental risk regulations, agency guidelines and internal policies to assure compliance.
Lead process improvement projects and assessment of quality plans.
Support Management during external/internal inspections and participate in the management of external/internal inspections.
Assist with external/internal audit preparation and responses to external / internal audit observations.
Maintain working knowledge of domestic and international medical device regulations and guidance documents and their impact on client's operations.
CAPA Management & Root Cause Analysis Tools
Technical writing skillset
experience writing and reviewing QMS related documentation for ISO 13485 and EU MDR compliance
Product Service Quality experience preferred
Requirements:
Bachelor's Degree in Engineering, Science or technical field with 5+ years of work experience in Engineering and/or Quality OR Master's Degree Engineering, Science or technical field with 3+ years of work experience in Engineering and/or Quality.
Auditing experience to 21CFR820.30, 21CFR820.100, ISO13485, IS0 14971:2012, CMDR, the Medical Device Directive and MDSAP.
Training in Risk Management, ISO 14971:2012, hazard analysis, and Design FMEA.
Master's degree in Engineering, Program Management, or Compliance.
Lead Auditor Certification to ISO 13485:2016.
ASQ CQE, CQA, CSQE and/or CRE certification.
Familiar with statistical software tools (Minitab, Stat Graphics, Statistica).
Familiar with IEC 60601 and product specific industry standards.
Excellent interpersonal and influence skills including efficient collaboration, effective negotiation, and creative problem solving.
Strong technical experience in complex technology development programs including ability to understand technical information, discuss/decide on a wide array of engineering disciplines and technical/logistical issues.